None listed
Conditions
Brief summary
Functional defecation disorders are the underlying causes of one third of all constipation and half of all fecal incontinence. Anorectal biofeedback therapy is a safe and effective form of rehabilitation therapy that uses anorectal muscle exercises to restore normal bowel function. However, due to access and cost issues biofeedback therapy is not accessible to most patients. This randomized controlled trial involves an experimental internet-of-medical-things device that will aid in biofeedback therapy and allow for training to be conducted at a patient's home. We aim to compare therapy delivered using the experimental device against conventional clinic-based anorectal biofeedback therapy.
Interventions
An novel experimental device to aid in anorectal biofeedback therapy. The Internet-of-Medical-Things device consists of an insertable probe with sensors to collect data on anal sphincter muscle contractility and rectal lumen pressures. The probe is wirelessly connected to a mobile app to provide real-time visual feedback of muscle activities to the user. The app records and processes training session data and clinical indicators (symptoms & bowel diary) from user input. Processed data will be se
An novel experimental device to aid in anorectal biofeedback therapy. The Internet-of-Medical-Things device consists of an insertable probe with sensors to collect data on anal sphincter muscle contractility and rectal lumen pressures. The probe is wirelessly connected to a mobile app to provide real-time visual feedback of muscle activities to the user. The app records and processes training session data and clinical indicators (symptoms & bowel diary) from user input. Processed data will be sent to a cloud server to allow health providers to track progress and aid in decision-making. The proposed device will allow for instrumented anorectal biofeedback training to be performed by users at a clinic or at home. Participant involvement The study will be conducted a GI Motility Clinic at Camden Public Hospital, NSW Australia. Participants will be randomly assigned into conventional biofeedback therapy or biofeedback therapy with the new experimental device. The specialist nurse at the GI Motility Clinic will educate the participant on bowel function and perform the therapy (either with conventional equipment or experimental device). Training involves inserting a sensing probe into the anorectal cavity and performing a series of pulse squeeze, squeeze & hold, and push muscle maneuvers. Real-time feedback will be provided to the participant in the formal of verbal cues (conventional therapy) or visual graphics (experimental device). Participants using experimental device may take the device home in between clinical sessions to continue with training for the duration of their therapy period. Participants will be provided with training on how to operate the device at the clinic and a physical instruction manual. Home training is recommended at one session per day, each session takes 5 - 10 minutes to complete. Both arms of the trial will take 6 weekly clinical sessions. Each session will take approximately 30 minutes to 1 hour.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Males and females 18 to 65 years • Diagnosed with urge faecal incontinence or faecal seepage • Able to provide verbal and written consent
Exclusion criteria
• Pregnant women and the human foetus • People under the age of 18 • People with a cognitive impairment, an intellectual disability or a mental illness • Anorectal surgery within the last 3 years • Presence of active anal fissure and/or symptomatic haemorrhoids • Individuals with implantable or portable electro-mechanical medical devices (e.g. pacemaker, sacral nerve stimulation impact)
Outcome results
None listed